- In March, Novartis/Sandoz's Zarxio (filgrastim-sndz) became the first biosimilar approved in the U.S. It is the biosimilar version of Amgen's Neupogen.
- Amgen is now claiming in court that Sandoz failed to implement Biologics Price Competition and Innovation Act (BPCIA) provisions properly.
- Prior to approval of Zarxio, on Feburary 5, Amgen filed a motion in a Northern California district court seeking an injunction against Novartis/Sandoz to prevent the marketing of Zarxio.
Now that biosimilar drugs are starting to come up for approval in the U.S. (the very first being Zarxio), the Biologics Price Competition and Innovation Act of 2010 is being tested for the first time. There are many technicalities and nuances, but at issue is how Novartis handled the process of alerting Amgen that it was filing for biosimilar approval of its version of filgrastim.
The market is ready for Zarxio, which is a biosimilar version of Neupogen, a drug that was originally approved by the FDA in 1991 and is used to help increase cancer patients' white blood cell counts and ward off infections. While it's not clear what the cost differential between Neupogen and Zarxio will be, Zarxio is bound to be cheaper than Neupogen, which costs $3,000 per chemotherapy cycle (before discounts and rebates are taken into consideration).
This case is being watched closely because whatever the court decides will become a precedent and provide guidance for the entire industry.